- Email: [email protected]
Animal health pharmaceutical industry
Preventive Veterinary Medicine 73 (2006) 217–220 www.elsevier.com/locate/prevetmed
Animal health pharmaceutical industry Richard A. Carnevale a,*, Thomas R. Shryock b a
b
Animal Health Institute, 1325 G Street Suite 700, Washington, DC 20005, USA Elanco Animal Health, 2001 W. Main St., GL21, P.O. Box 708, Greenfield, IN 46140, USA
Abstract The animal health pharmaceutical industry has proactively reported on the volumes of member company antimicrobial active ingredients sold in the U.S. At the individual company level, reporting of finished product distribution data to the FDA is a regulatory requirement, with applications to surveillance and pharmacovigilance. An accounting of product manufactured is done for purposes of good business practices, as well as marketing analyses. Additional applications of antimicrobial usage data might include use in risk assessments, such as for the FDA’s Center for Veterinary Medicine Guidance for Industry #152 for the evaluation of the microbiological safety of antimicrobials intended for use in food animals. Compilation of national usage data will be a complex undertaking, hindered by issues such as confidentiality, auditing, field use practice variations, population dynamics (e.g. disease incidence, market conditions for poultry and livestock production), and generic usage. The amounts or volumes in pounds should be considered relative to the large number of animals under husbandry in the United States. Large volumes might seem impressive unless put into proper context. Until such time as a clearly defined application of national usage data is agreed, it is recommended that local usage programs will provide more useful information to perpetuate prudent antimicrobial use in animals. # 2005 Elsevier B.V. All rights reserved. Keywords: Antimicrobial; Usage; Animal; Health
The Animal Health Institute (AHI) represents both U.S. and global manufacturers of veterinary pharmaceutical, feed additive, and biological products. AHI welcomes participation in committees, symposia, and other activities where antimicrobial agents * Corresponding author. Tel.: +1 202 637 2440; fax: +1 202 393 1667. E-mail address: [email protected] (R.A. Carnevale). 0167-5877/$ – see front matter # 2005 Elsevier B.V. All rights reserved. doi:10.1016/j.prevetmed.2005.09.009
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R.A. Carnevale, T.R. Shryock / Preventive Veterinary Medicine 73 (2006) 217–220
used in animals are discussed in order to provide its perspective and experience that cannot be obtained from other sectors. At the invitation of the Alliance for the Prudent Use of Antibiotics (APUA), AHI is participating in this FAAIR II exercise to address the feasibility of, and possible use of, data that might be collected on the amounts of antimicrobial products manufactured and used in animals in the U.S. In the U.S., AHI has proactively surveyed member companies to obtain national volumes data for these purposes (http://www.ahi.org/mediaCenter/documents/Antibioticuse2004.pdf). The type of data reported has been on the basis of the total pounds of a class of antimicrobial agent sold in a calendar year and without regard to the individual claim or species of animal medicated because this information is frequently not known for many products. AHI protects the release of data on individual compounds where there are only one or two manufacturers. Why are quantitative antimicrobial use data important to the animal health pharmaceutical industry? Industry wishes to inform all stakeholders about antimicrobial usage in as open a way as possible, within the constraints of what our member companies permit. Manufacturers of veterinary antimicrobial agents maintain proprietary internal accounting records of drug products for specific business, regulatory, and legal reasons. For example, manufacturers of antimicrobial agents keep track on their own company’s production operations for reasons related to quality control (e.g. lot acceptance rate), assessment of cost of product sold and inventory control to balance supply with demand (including expiration, breakage, etc.), and distribution flow. These activities are designed to comply with sound business practices. There is a legal obligation under the Federal Food, Drug, and Cosmetic Act to report to the Food and Drug Administration’s (FDA) Center for Veterinary Medicine the number of units of individual products sold within the last year based on the anniversary date of approval. The type of information reported would be the number of bottles of a product sold (e.g. the number of 100 mL bottles, the number of 50 mL bottles, etc.) or the number of bags of Type A premix. Unless the product has a single species and label indication, it is impossible to ascertain the ultimate end use of the product. These yearly sales figures are considered to be trade secrets or proprietary business information because competitors could use this information to determine market share of particular products. Product distribution data are also an important component of pharmacovigilance programs. These data are required by the FDA as part of the post-marketing surveillance and compliance regulations and are matched to all potential adverse drug reactions reported by veterinarians, producers and consumers for a particular product. The data are used primarily to calculate rates of adverse reactions from year to year to assess how significant the incidence of any potential adverse drug reactions may be by evaluating number of reactions against exposure. National and regional usage data, compiled by various means, are useful to companies to identify when marketing opportunities might exist and how successful their competitors may be in penetrating certain markets. These kinds of data are obtained by commercial firms that conduct customer surveys to compile national product sales data, or by
R.A. Carnevale, T.R. Shryock / Preventive Veterinary Medicine 73 (2006) 217–220
219
internal company groups that assess sales data within a particular business unit (e.g. a swine business unit might tabulate sales data for key customers). Compilation into regional or national data is contingent upon the ability to accurately obtain local usage data. Usage data may be important to collect because of the potential to promote/sustain prudent use practices. Usage data may also be incorporated into risk assessments. How might the animal health pharmaceutical industry make use of antimicrobial use data? Usage data collection approaches can be compiled at the local (production location), community, state or regional level, and perhaps national level. The most useful data to support prudent use will be that collected at a particular local production site, especially when it is coupled with clinical response data, antibiograms, and other ‘‘context’’ data such as weather, price increases, market conditions, etc., that would enable an understanding of observed changes of use patterns over time. This type of usage data collection could be considered as a ‘‘demonstration trial’’ that could be used as an example to other producers or veterinarians in their local area. An additional application of local data is to support marketing efforts among companies, relative to the effectiveness of the appropriate use of their products. From the pharmaceutical manufacturer’s perspective, local usage data, coupled with other inputs, can be used by the field technical personnel to educate customers, veterinarians, and allied animal health personnel in the appropriate usage of products. This initiative can be tied directly to marketing programs that seek to sustain the effectiveness of antibiotic use in veterinary medicine and food animal production, while minimizing public health impact. One USDA program, the Collaboration of Animal Health and Food Safety Epidemiology (CAHFSE), seeks to combine these parameters into an ongoing evaluation and holds promise as the best method to collect usage data (http:// www.aphis.usda.gov/cahfse/index.htm). Compilation of regional or national data might be most useful to risk assessors to incorporate into their on-farm or Release Assessment component, as found in CVM Guidance #152. However, simply collecting total usage data on a product specific basis will not provide any context information that will be required to explain unanticipated patterns observed over time. For example, a sharp decline in the usage of a given antibiotic might be explained by a manufacturer’s shortage. An increase might be explained by weather that caused higher than normal morbidity in cattle in the fall. In other words, beyond simply collecting the data, there is no basis of cause and effect to understand the reason for the change. Thus, the larger geographic compilation, or accounting, of products cannot be effectively used to further the local usage practices. Additional issues or concerns pertaining to antimicrobial use surveillance that are particularly relevant to the animal health pharmaceutical industry.
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R.A. Carnevale, T.R. Shryock / Preventive Veterinary Medicine 73 (2006) 217–220
The animal health pharmaceutical industry believes that antibiotic usage collection data are important but should be targeted to the particular need, in this case, to assess the potential impact of usage on selection of antimicrobial resistance in animal pathogens and animal derived human food borne pathogens. Collection of aggregate data on a national or regional basis, while helpful as a yardstick to measure total production and usage or to compare usage between countries, is not the best means to satisfy this objective. Issues related to dosage forms, actual field usage practices of products, generic uses, and human drug product uses (particularly for companion or exotic animals), remain. Issues related to confidentiality, anti-trust compliance, and data assurance by third party participants remain. Suggestions for overcoming obstacles to data collection, data use, or policy. A resource-efficient program, with clearly defined goals, as a long-term goal, might be considered. As mentioned, the animal health pharmaceutical industry wants to avoid a premature implementation of a national program for the sake of data collection, without establishing a causal relationship to efficacy or other measurement of effect. Given the corporate experience of providing usage data so far, the technical, commercial, and practical limitations have been more than anticipated. In the meantime, collection of data at the local level within the framework of a scientific study or program with clearly delineated objectives where direct comparisons with resistance frequencies can be ascertained would seem to be more useful.
Animal health pharmaceutical industry Richard A. Carnevale a,*, Thomas R. Shryock b a
b
Animal Health Institute, 1325 G Street Suite 700, Washington, DC 20005, USA Elanco Animal Health, 2001 W. Main St., GL21, P.O. Box 708, Greenfield, IN 46140, USA
Abstract The animal health pharmaceutical industry has proactively reported on the volumes of member company antimicrobial active ingredients sold in the U.S. At the individual company level, reporting of finished product distribution data to the FDA is a regulatory requirement, with applications to surveillance and pharmacovigilance. An accounting of product manufactured is done for purposes of good business practices, as well as marketing analyses. Additional applications of antimicrobial usage data might include use in risk assessments, such as for the FDA’s Center for Veterinary Medicine Guidance for Industry #152 for the evaluation of the microbiological safety of antimicrobials intended for use in food animals. Compilation of national usage data will be a complex undertaking, hindered by issues such as confidentiality, auditing, field use practice variations, population dynamics (e.g. disease incidence, market conditions for poultry and livestock production), and generic usage. The amounts or volumes in pounds should be considered relative to the large number of animals under husbandry in the United States. Large volumes might seem impressive unless put into proper context. Until such time as a clearly defined application of national usage data is agreed, it is recommended that local usage programs will provide more useful information to perpetuate prudent antimicrobial use in animals. # 2005 Elsevier B.V. All rights reserved. Keywords: Antimicrobial; Usage; Animal; Health
The Animal Health Institute (AHI) represents both U.S. and global manufacturers of veterinary pharmaceutical, feed additive, and biological products. AHI welcomes participation in committees, symposia, and other activities where antimicrobial agents * Corresponding author. Tel.: +1 202 637 2440; fax: +1 202 393 1667. E-mail address: [email protected] (R.A. Carnevale). 0167-5877/$ – see front matter # 2005 Elsevier B.V. All rights reserved. doi:10.1016/j.prevetmed.2005.09.009
218
R.A. Carnevale, T.R. Shryock / Preventive Veterinary Medicine 73 (2006) 217–220
used in animals are discussed in order to provide its perspective and experience that cannot be obtained from other sectors. At the invitation of the Alliance for the Prudent Use of Antibiotics (APUA), AHI is participating in this FAAIR II exercise to address the feasibility of, and possible use of, data that might be collected on the amounts of antimicrobial products manufactured and used in animals in the U.S. In the U.S., AHI has proactively surveyed member companies to obtain national volumes data for these purposes (http://www.ahi.org/mediaCenter/documents/Antibioticuse2004.pdf). The type of data reported has been on the basis of the total pounds of a class of antimicrobial agent sold in a calendar year and without regard to the individual claim or species of animal medicated because this information is frequently not known for many products. AHI protects the release of data on individual compounds where there are only one or two manufacturers. Why are quantitative antimicrobial use data important to the animal health pharmaceutical industry? Industry wishes to inform all stakeholders about antimicrobial usage in as open a way as possible, within the constraints of what our member companies permit. Manufacturers of veterinary antimicrobial agents maintain proprietary internal accounting records of drug products for specific business, regulatory, and legal reasons. For example, manufacturers of antimicrobial agents keep track on their own company’s production operations for reasons related to quality control (e.g. lot acceptance rate), assessment of cost of product sold and inventory control to balance supply with demand (including expiration, breakage, etc.), and distribution flow. These activities are designed to comply with sound business practices. There is a legal obligation under the Federal Food, Drug, and Cosmetic Act to report to the Food and Drug Administration’s (FDA) Center for Veterinary Medicine the number of units of individual products sold within the last year based on the anniversary date of approval. The type of information reported would be the number of bottles of a product sold (e.g. the number of 100 mL bottles, the number of 50 mL bottles, etc.) or the number of bags of Type A premix. Unless the product has a single species and label indication, it is impossible to ascertain the ultimate end use of the product. These yearly sales figures are considered to be trade secrets or proprietary business information because competitors could use this information to determine market share of particular products. Product distribution data are also an important component of pharmacovigilance programs. These data are required by the FDA as part of the post-marketing surveillance and compliance regulations and are matched to all potential adverse drug reactions reported by veterinarians, producers and consumers for a particular product. The data are used primarily to calculate rates of adverse reactions from year to year to assess how significant the incidence of any potential adverse drug reactions may be by evaluating number of reactions against exposure. National and regional usage data, compiled by various means, are useful to companies to identify when marketing opportunities might exist and how successful their competitors may be in penetrating certain markets. These kinds of data are obtained by commercial firms that conduct customer surveys to compile national product sales data, or by
R.A. Carnevale, T.R. Shryock / Preventive Veterinary Medicine 73 (2006) 217–220
219
internal company groups that assess sales data within a particular business unit (e.g. a swine business unit might tabulate sales data for key customers). Compilation into regional or national data is contingent upon the ability to accurately obtain local usage data. Usage data may be important to collect because of the potential to promote/sustain prudent use practices. Usage data may also be incorporated into risk assessments. How might the animal health pharmaceutical industry make use of antimicrobial use data? Usage data collection approaches can be compiled at the local (production location), community, state or regional level, and perhaps national level. The most useful data to support prudent use will be that collected at a particular local production site, especially when it is coupled with clinical response data, antibiograms, and other ‘‘context’’ data such as weather, price increases, market conditions, etc., that would enable an understanding of observed changes of use patterns over time. This type of usage data collection could be considered as a ‘‘demonstration trial’’ that could be used as an example to other producers or veterinarians in their local area. An additional application of local data is to support marketing efforts among companies, relative to the effectiveness of the appropriate use of their products. From the pharmaceutical manufacturer’s perspective, local usage data, coupled with other inputs, can be used by the field technical personnel to educate customers, veterinarians, and allied animal health personnel in the appropriate usage of products. This initiative can be tied directly to marketing programs that seek to sustain the effectiveness of antibiotic use in veterinary medicine and food animal production, while minimizing public health impact. One USDA program, the Collaboration of Animal Health and Food Safety Epidemiology (CAHFSE), seeks to combine these parameters into an ongoing evaluation and holds promise as the best method to collect usage data (http:// www.aphis.usda.gov/cahfse/index.htm). Compilation of regional or national data might be most useful to risk assessors to incorporate into their on-farm or Release Assessment component, as found in CVM Guidance #152. However, simply collecting total usage data on a product specific basis will not provide any context information that will be required to explain unanticipated patterns observed over time. For example, a sharp decline in the usage of a given antibiotic might be explained by a manufacturer’s shortage. An increase might be explained by weather that caused higher than normal morbidity in cattle in the fall. In other words, beyond simply collecting the data, there is no basis of cause and effect to understand the reason for the change. Thus, the larger geographic compilation, or accounting, of products cannot be effectively used to further the local usage practices. Additional issues or concerns pertaining to antimicrobial use surveillance that are particularly relevant to the animal health pharmaceutical industry.
220
R.A. Carnevale, T.R. Shryock / Preventive Veterinary Medicine 73 (2006) 217–220
The animal health pharmaceutical industry believes that antibiotic usage collection data are important but should be targeted to the particular need, in this case, to assess the potential impact of usage on selection of antimicrobial resistance in animal pathogens and animal derived human food borne pathogens. Collection of aggregate data on a national or regional basis, while helpful as a yardstick to measure total production and usage or to compare usage between countries, is not the best means to satisfy this objective. Issues related to dosage forms, actual field usage practices of products, generic uses, and human drug product uses (particularly for companion or exotic animals), remain. Issues related to confidentiality, anti-trust compliance, and data assurance by third party participants remain. Suggestions for overcoming obstacles to data collection, data use, or policy. A resource-efficient program, with clearly defined goals, as a long-term goal, might be considered. As mentioned, the animal health pharmaceutical industry wants to avoid a premature implementation of a national program for the sake of data collection, without establishing a causal relationship to efficacy or other measurement of effect. Given the corporate experience of providing usage data so far, the technical, commercial, and practical limitations have been more than anticipated. In the meantime, collection of data at the local level within the framework of a scientific study or program with clearly delineated objectives where direct comparisons with resistance frequencies can be ascertained would seem to be more useful.